Prostate diseases such as prostatitis, benign prostatic hypertrophy, prostatodynia, and prostate carcinoma afflict many adult males. The largest segment of the population of men stricken with prostate problems includes those over age fifty. However, inherited prostate problems can appear in much younger men.
Benign prostatic hypertrophy (BPH) is a condition where the prostate over-grows or becomes enlarged. Prostate growth is controlled by androgen receptors found in the prostate gland. It is generally believed that when the androgen receptors are stimulated by 5-alpha-dihydrotesterone (DHT), they cause the prostate to grow. DHT is produced by an enzymatic conversion of testosterone in the prostate.
Over the past twenty years a variety of approaches have been developed to treat benign prostatic hypertrophy. In general, these approaches alter the prostatic tissue volume or the biochemistry of the prostate, and they include the application of heat, cold, chemical agents, pharmaceutical agents and radiation. In recent years, a number of minimally invasive technologies have been developed, including radiation, RF ablation, microwave ablation, cryogenic ablation/freezing, and chemo-ablation. Chemo-ablative approaches, including injection of alcohol or salt solutions, have been evaluated for the treatment of benign prostatic hypertrophy. However, the lack of delivery control when administering ablative liquids has led to unpredictable retention of the same, leading to nonspecific ablation of both the prostate as well as surrounding tissues and organs.
The present invention is therefore directed to the problem of developing a method and apparatus for delivering formulations in a controlled manner into the human body, for example, into prostatic tissue, including chemotherapy to treat BPH and brachytherapy to treat prostate cancer, as well as periurethral delivery of bulking agents to treat stress urinary incontinence (SUI), and the delivery of other localized drug/therapeutic formulations to treat other benign or malignant tissue conditions in other areas of the body.